FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T99-40                                                      Sharon Snider:       301-827-6242 
August 24, 1999                                                                                        
                                                            Consumer Inquiries:  888-INFO-FDA

THE YEAR 2000 DATE PROBLEM and MEDICAL DEVICES

FDA has been receiving inquiries about the effect the Year 2000 (Y2K) date change will have on computer-controlled medical devices and FDA's role in assuring these products will function safely and effectively on January 1, 2000. The following Q & A s should help put the issue in perspective.

What is FDA's role?

FDA is responsible for assuring the safety and effectiveness of the products it regulates. In mid-1996, FDA began internal discussions on the potential for medical devices to be adversely affected by the Y2K date problem. The problem can occur in products that were programmed to recognize only the last two digits of a year, assuming the first two would be 1 and 9. On Jan. 1, 2000, unprepared machines will understand the year "00" not as 2000 but as 1900, which may cause them to shut down or stop working properly. Since mid-1996, FDA has been working aggressively with the medical device industry and the healthcare community to assure that medical devices will continue to work as they should. These efforts included stating FDA's expectations for manufacturers and providing information on product status to the healthcare community.

Will medical devices be adversely affected by the Y2K date change?

The vast majority of computer-controlled medical devices used and marketed in the United States will not be significantly affected by the Y2K date problem. Only about 2,000 of the nation's 13,500 medical device manufacturers make products that are the type that might be controlled by a computer and, therefore, potentially sensitive to Y2K problems. Most of these do not depend on a date to function properly. However, there are a few products--primarily used in hospitals and laboratories--in which correct processing of date information is critical to the device's effective functioning.

What are these products and what has been done to ensure their safety?

Devices that could potentially be affected by the Y2K date problem include products that use dates in a calculation or algorithm or for critical record keeping such as radiation therapy treatment planning systems, hemodialysis machines, some clinical laboratory systems, some blood product devices, and some ultrasound systems. FDA has compiled a list of medical device types that, if computer-controlled and subject to a Y2K failure, present a potential for causing serious adverse events. (This information is available on FDA's web site at www.fda.gov/cdrh/yr2000/year2000.html under the heading "Information for Healthcare Facilities.") Most manufacturers have already identified solutions and provided upgrades for these types of devices and have notified their customers (hospitals and other healthcare facilities) of their availability.

What about home medical devices and implanted devices like pacemakers and defibrillators?

Few, if any, of these products will be affected by the Y2K problem because most do not depend on a current date to operate safely and effectively. Pacemakers, defibrillators and other implanted devices will not be affected. Some products that use computers to record data, such as some glucose monitors, could be affected.

What action has FDA taken so far?

Among the numerous actions taken:

In June, 1997, FDA alerted the medical device industry to the potential for a problem with computer-controlled/date- sensitive devices. The agency put manufacturers on notice that they were responsible for assessing all their products. Companies were informed that, if a potential problem were identified, the manufacturer must provide or make available an upgrade to the device, inform their customers not to use it, or provide information on how it can be modified to avoid a problem. FDA has continued to work closely with the medical device industry to assure medical devices are ready for Y2K.
In March 1998, with cooperation from other Executive Departments, FDA established a clearinghouse for information on the status of biomedical equipment. The clearinghouse is designed to give hospitals, medical research facilities, government agencies and the general public a single, comprehensive source of information on the Y2K status of medical devices and scientific research equipment. FDA asked manufacturers to provide information on the status of their products. This information is available on FDA's web site at: www.fda.gov/cdrh/yr2000/year2000.html.
In July 1999, FDA issued a public health notice to hospitals and other healthcare facilities alerting them to the need to address Y2K issues with medical devices and informing them of the product information available on FDA's web site. FDA also reminded them of the requirements to report device- related adverse events, including any caused by the Y2K problem, under FDA's Medwatch reporting program.

What does the manufacturers' information show about their products?

In reviewing the data to date, FDA sees no indication of widespread problems which will place patients at risk as long as the solutions now offered by manufacturers are implemented by hospitals, other medical facilities and device users.

How does FDA know that the data provided by manufacturers is accurate?

To verify that manufacturers are taking necessary steps to be ready for Y2K, FDA checks during regular inspections of manufacturing facilities to see what the firm has done to assure that its products, manufacturing process and distribution systems are Y2K compliant. If FDA investigators encounter serious problems or find that firms are not taking appropriate steps to avoid serious Y2K problems, the agency will follow up with regulatory action where appropriate.

In addition, to help provide further assurance of the adequacy of manufacturers' Y2K-related activities, FDA has initiated a study of Y2K readiness of potentially high-risk medical devices. FDA has asked a sampling of manufacturers of potentially high-risk products to undergo voluntary assessment of their facilities to check their procedures and records and to validate any Y2K corrections they have made. The study results will be reported in October.

Can FDA recall a product if it's not Y2K compliant?

FDA has the authority to require a mandatory recall of a medical device that presents "an unreasonable risk of substantial harm to the public health." The agency can also require manufacturers to notify customers about devices that present such a risk. Normally, manufacturers voluntarily recall problematic devices without FDA having to require a mandatory action. Mandatory recalls are undertaken in only the most severe situations.

FDA does not expect the Y2K date problem to lead to device failures of the type that would warrant a mandatory recall. If a recall is needed, FDA expects the manufacturer to recall the product voluntarily under FDA oversight.

For more information on FDA and Y2K, go to www.fda.gov/oc/y2k/. [Note, 3-9-2005: This site no longer exists.]

FDA TALK PAPER